NCT00567112

Brief Summary

A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \& oral compressed tablet (OCT) formulations of MK-0941-009 \& to assess the effect of food on the OCT formulation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

September 5, 2012

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

November 30, 2007

Results QC Date

July 17, 2012

Last Update Submit

March 12, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

  • Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)

    From study drug administration to 72 hours post-administration

  • Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)

    From study drug administration to 72 hours post-administration

  • Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)

    From study drug administration to 72 hours post-administration

  • Half Life (t½) for OCT (Fasted) and DFC (Fasted)

    From study drug administration to 72 hours post-administration

Secondary Outcomes (4)

  • AUC(0-∞) for OCT (Fasted) and OCT (After Meal)

    From study drug administration to 72 hours post-administration

  • Cmax of OCT (Fasted) and OCT (After Meal)

    From study drug administration to 72 hours post-administration

  • Tmax for OCT (Fasted) and OCT (After Meal)

    From study drug administration to 72 hours post-administration

  • t1/2 for OCT (Fasted) and OCT (After Meal)

    From study drug administration to 72 hours post-administration

Study Arms (4)

DFC (fasted)

EXPERIMENTAL
Drug: 10 mg MK-0941 DFC (fasted)

OCT (fasted)

EXPERIMENTAL
Drug: 10 mg MK-0941 OCT (fasted)

OCT (after meal)

EXPERIMENTAL
Drug: 10 mg MK-0941 OCT (after meal)

OCT (before meal)

ACTIVE COMPARATOR
Drug: 10 mg MK-0941 OCT (before meal)

Interventions

10 mg MK-0941 DFC (fasted)DRUG

single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state

DFC (fasted)
10 mg MK-0941 OCT (after meal)DRUG

single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal

OCT (after meal)
10 mg MK-0941 OCT (before meal)DRUG

single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast

OCT (before meal)
10 mg MK-0941 OCT (fasted)DRUG

single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state

OCT (fasted)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females (of non-childbearing potential) between the ages of 18 to 70
  • Participants have been diagnosed with Type 2 Diabetes
  • Participants are nonsmokers for at least 6 months

You may not qualify if:

  • Participant should not be diagnosed with Type 1 diabetes
  • Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start
  • Participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start
  • Participant has been diagnosed with glaucoma or is blind
  • Participant has had trauma to one or both eyes
  • Participant has had major surgery, donated blood or participated in another clinical study in the past 4 weeks
  • Participant is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Postprandial Period

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

November 1, 2007

Primary Completion

February 1, 2008

Study Completion

April 1, 2008

Last Updated

March 23, 2015

Results First Posted

September 5, 2012

Record last verified: 2015-03